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Completed

NCT Number: NCT06715163

Evaluation of the Safety and Tolerability of Three Doses of Diamine Oxidase (DAO) in Healthy Volunteers

The main aim of this study is to evaluate the safety and tolerability of the product administered, of 3 different doses. Safety will be evaluated by recording and assessing adverse events, vital signs, laboratory tests and ECG. These assessments will be conducted during the study and at the end the study, following the study schedule and evaluation times. Since it is not absorbed and considering the conducted studies, 24 h are sufficient to analyse the safety and tolerability of the product. Safety will be assessed until the follow up visit, 6-8 days after product intake, to check possible adverse effects during that time.

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Key information

Conditions

Safety and Tolerability in Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - Subjects of either gender (male or female) aged ≥18 and ≤50 years at the time of the enrolment.
  • - Subjects free from organic or psychic conditions.
  • - No clinically significant abnormalities in medical records and physical examination at screening.
  • - No clinically significant abnormalities in haematology, biochemistry, serology (HBsAg, HCV antibodies, HIV antibodies) and urine drug results.
  • - Vital signs (blood pressure, respiratory rate, body temperature and pulse rate) and electrocardiogram record without clinically significant abnormalities.
  • - Body weight within the range (BMI ≥ 18.5 and ≤30.0 kg/m2) expressed as weight (kg) / height (m2).
  • - Free acceptance to participate in the study by obtaining signed informed consent form approved by the Ethics Committee of the Hospital (CEIm).

Exclusion criteria

  • - Background of allergy, idiosyncrasy or hypersensitivity to Investigational or any products or food
  • - Heavy consumers of stimulating drinks (>5 cups of coffee, tea, chocolate or cola drinks per day).
  • - Background History of alcohol dependence or drug abuse in the last 5 years or daily consumption of alcohol > 40 gr/day for men or 24 gr/day for women.
  • - Intake of any medication within 14 days prior to taking the study treatment (except for use of paracetamol short-term symptomatic treatments, according to the investigator criteria), or intake of over-the-counter products (including natural food supplements, vitamins and medicinal plants products) within 7 days prior taking the study treatment.
  • - Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
  • - Positive results for abuse drugs in urine test or ethanol in breath test (Day-1).
  • - Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological, neurological disease or other chronic diseases.
  • - Females with positive results from the pregnancy test or breast-feeding.
  • - Smoking within 6 months prior to the study treatment phase (Period 1, Day -1). Smokers must refrain from any tobacco usage, including smokeless tobacco, nicotine patches, electronic cigarettes, etc. at least for 6 months prior to study treatment.
  • - Mentally or legally incapacitated at screening.
  • - Unwillingness or inability to follow the procedures outlined in the protocol.
  • - Volunteers who have difficulties in understanding the language in which the volunteer information is given.
  • - Any condition that, in the opinion of the investigator, may jeopardise the patient's well-being or the trial conduct according to the protocol.

Treatment and study plan

Dose 1 (42mg) of DAO

Dietary Supplement

DAO extract is obtained from pea sprout dehydrated powder. Lowest dose of DAO administered in this study

Other names: diamino oxidase (DAO)

Placebo

Dietary Supplement

Contains the same excipients as the DAO tablets but without the diamino oxidase content

Dose 2 (84mg) of DAO

Dietary Supplement

DAO extract is obtained from pea sprout dehydrated powder. Medium dose of DAO administered in this study

Dose 3 (210mg) of DAO

Dietary Supplement

DAO extract is obtained from pea sprout dehydrated powder. Highest dose of DAO administered in this study

Primary outcomes

  1. Vital signs - blood pressure

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    Systolic blood pressure (mmHg) and Diastolic blood pressure (mmHg)

  2. Vital signs - Heart Rate

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    Heart rate as bpm (beats per minute)

  3. Vital signs - Respiratory Rate

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    Respiratory rate as bpm

  4. Vital signs - temperature

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    Body temperature as ºC (Celsius degrees)

  5. ECG - Ventricular Rate (HR)

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    Electrocardiogram: Ventricular rate (bpm)

  6. ECG - PR interval

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    Electrocardiogram: PR interval (ms)

  7. ECG - QRS interval

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    Electrocardiogram: QRS interval (ms)

  8. ECG - QT interval

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    Electrocardiogram: QT interval (ms)

  9. ECG - QTc interval

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    Electrocardiogram: QTc interval through Bazett's formula (ms)

  10. Laboratory analyses - Concentrations of Glucose, Urea, Triglycerides, Cholesterol measured as mmol/L

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    BIOCHEMISTRY: Concentrations of Glucose, Urea, Triglycerides, Cholesterol measured as mmol/L

  11. Laboratory analyses - Concentrations of Creatinine, Total Bilirubin measured as micromol/L

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    BIOCHEMISTRY: Concentrations of Creatinine, Total Bilirubin measured as micromol/L

  12. Laboratory analyses - Concentrations of GOT (AST), GPT (ALT), GGT, Alkaline Phosphatase measured as U/L

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    BIOCHEMISTRY: Concentrations of GOT (AST), GPT (ALT), GGT, Alkaline Phosphatase measured as U/L.

  13. Laboratory analyses - Concentrations of Albumin, Haemoglobin, CCMH measured as g/L.

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    BIOCHEMISTRY: Concentrations of Albumin measured as g/L. HAEMATOLOGY: Concentrations of Haemoglobin, CCMH measured as g/L.

  14. Laboratory analyses - Concentration of Haematocrit as L/L

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    HAEMATOLOGY: Concentration of Haematocrit as L/L

  15. Laboratory analyses - Concentration of Platelet count, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes measured as x10E9/L

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    HAEMATOLOGY: Concentration of Platelet count, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes measured as x10E9/L.

  16. Laboratory analyses

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    SEROLOGY: HIV, HBV and HCV measured through ELISA analysis as presence or absence (positive or negative result).

  17. Laboratory analyses

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    SCREENING of DRUGS of ABUSE in URINE: ethanol, cannabis, amphetamines, cocaine, opiates and benzodiazepines measured as presence or absence (positive or negative result).

  18. Incidence of adverse events

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

    Assessment through the opinion of the Investigator, who should consider if it is contraindicative to continue the volunteer's participation in the study if the volunteer experienced adverse events severe enough.

Sponsors and collaborators

Lead sponsor

AB Biotek

Industry

Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Registry information

Acronym: DAO-MAX2024

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2024
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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